NCT04503824

Brief Summary

Observational case-control study. The current study aims to assess the salivary expression of lncRNA DQ786243 and IL-17 in OLP, to better understand the pathogenesis of OLP and provide effective targets for OLP therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2021

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

1.5 years

First QC Date

August 5, 2020

Last Update Submit

August 5, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Salivary expression of lncRNA DQ786243. Salivary expression of lncRNA DQ786243. Salivary expression of lncRNA DQ786243. Salivary expression of lncRNA DQ786243. ▪ Salivary expression of IL-17 and Salivary expression of lncRNA DQ786243.

    one year

Study Arms (4)

Group IIa: 13 papular OLP

Diagnostic Test: saliva samples

Group IIb: 13 atrophic OLP

Diagnostic Test: saliva samples

Group IIc: 13 erosive OLP

Diagnostic Test: saliva samples

Group I: 13 healthy individuals

Diagnostic Test: saliva samples

Interventions

saliva samplesDIAGNOSTIC_TEST

Salivary expression of lncRNA DQ786243 and IL-17 will be evaluated using qRT-PCR.

Group I: 13 healthy individualsGroup IIa: 13 papular OLPGroup IIb: 13 atrophic OLPGroup IIc: 13 erosive OLP

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

thestudy composes of two groups: healthy controls and OLP. The expression of the two markers will be compared between the two studied groups. In OLP group, the expression of the two markers will be correlated with pain and clinical assessment scores. In addition, OLP group will be subgrouped based on the clinical form: papular, atrophic, erosive. Data of all participants will be entered on Excel sheet. Each participant will be provided an ID number that will be used for data management and placed as a label for the samples. Group I: 13 healthy individuals Group IIa: 13 papular OLP Group IIb: 13 atrophic OLP Group IIc: 13 erosive OLP

You may qualify if:

  • Patients diagnosed with OLP.
  • Patient who will agree to participate in the study.
  • Patients who will accept to sign the informed consent.

You may not qualify if:

  • Patients suffering from any systemic disease.
  • Patients suffering from any local inflammatory disease or infection.
  • Pregnant and lactating women. ▪ Smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 12223, Egypt

RECRUITING

Related Publications (1)

  • Abdeldayem E, Rashed L, Ali S. Salivary expression of lncRNA DQ786243 and IL-17 in oral lichen planus: case-control study. BMC Oral Health. 2022 Jun 18;22(1):240. doi: 10.1186/s12903-022-02277-0.

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecterur

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 7, 2020

Study Start

January 5, 2020

Primary Completion

June 29, 2021

Study Completion

July 29, 2021

Last Updated

August 7, 2020

Record last verified: 2020-08

Locations